Abstract

The aim of study is to determine the stability of Esomeprazole magnesium trihydrate under environmental conditions and Accelerated stability chamber. The drug products of esomeprazole enteric-coated pellets are more sensitive to environmental factors like heat, humidity, and light. These factors affect the stability of the product if not stored under the necessary condition. A stability study of enteric-coated pellets of esomeprazole magnesium trihydrate was performed following the USP method. Stability testing was performed for a new pharmaceutical product. The accelerated test was performed for the evolution of the stability at climate change like 40°C±2°C and 75±5% relative humidity (RH). The newly formulated brands were kept in the accelerated chamber (40 ± 2 0C / 75 ± 5% RH) for six months. After three and six months, products were analyzed at the initial interval stage by a High- Performance liquid Chromatography with a UV detector. The other product brands at different stages were also analyzed in the mid-shelf shelf life, near to expired, and expired products by the HPLC method under environmental conditions. The chromatography method of HPLC is based on the UV detector using the mixture of mobile phase acetonitrile, Buffer, and Distilled Water with a ratio of 350 ml: 500 ml: 150 ml, respectively. The flow rate is 1ml/min and detected at 305nm. During stability studies checked the appearance, potency, and bioavailability. The newly formulated brands give results under limits and are considered stable products under accelerated conditions. But other brands at different stages give some results under the low range and out of average limit and are not stable products throughout and after the shelf life. This study helps to check the stability of the esomeprazole magnesium products throughout the shelf life under accelerated and environmental conditions.